MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F180NR HF 12/CS 1.7SA ETO; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500318N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists hemodialysis treatment with the fresenius optiflux 180 nr dialyzer (lot numbers unknown, products discarded) and patient symptoms of itching and cramping.Based on this information, the dialyzer cannot be excluded from the event.However, currently there is no objective evidence that a product malfunction with the fresenius optiflux dialyzer caused this event.It is well documented in evidenced based literature that dialyzer reactions are a known potential complication in hemodialysis.Additionally, the manufacturer instruction for use for the fresenius optiflux dialyzer includes a warning of hypersensitivity (allergic) reactions as a possible side effect with using this product.
Event or Problem Description
A user facility¿s facility administrator (fa) reported that during a patient¿s hemodialysis (hd) treatment using a fresenius dialyzer the patient experienced severe itching and leg cramping.This resulted in the patient ending hemodialysis treatment approximately 2 hours early.The nurse stated that the patient did not require hospitalization as there was no serious harm.The nurse confirmed the patient did not have any shortness of breath and vital signs remain stable (readings not provided).However, the nurse stated that the patient had a change to include rinsing the dialyzer with 2 liters of normal saline for subsequent dialysis treatments and a standing order for benadryl 50 mg intravenous (iv) for itching as needed in addition to the patient pre-medicating with benadryl at home.On(b)(6) 2026, the patient was switched to a gambro revaclear 300 dialyzer.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Four lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one or more approved temporary deviation notice (dn) reported on nine of the lots which were unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lots met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.
Event or Problem Description
A user facility¿s facility administrator (fa) reported that during a patient¿s hemodialysis (hd) treatment using a fresenius dialyzer the patient experienced severe itching and leg cramping.This resulted in the patient ending hemodialysis treatment approximately 2 hours early.The nurse stated that the patient did not require hospitalization as there was no serious harm.The nurse confirmed the patient did not have any shortness of breath and vital signs remain stable (readings not provided).However, the nurse stated that the patient had a change to include rinsing the dialyzer with 2 liters of normal saline for subsequent dialysis treatments and a standing order for benadryl 50 mg intravenous (iv) for itching as needed in addition to the patient pre-medicating with benadryl at home.On 2/4/2026, the patient was switched to a gambro revaclear 300 dialyzer.

• Brand Name: OPTIFLUX F180NR HF 12/CS 1.7SA ETO
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 24314414
• Report Number: 0001713747-2026-00073
• Device Sequence Number: 5650635
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0500318N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 67 KG